Medical device eye pack manufactured by DeRoyal Industries recalled
DeRoyal Industries voluntarily recalled 72 kits of its EYE PACK medical device. The affected lot (Lot 57344921, exp. November 1, 2026) was distributed across multiple U.S. states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall initiated voluntarily by the manufacturer with no reported illnesses, injuries, or deaths. Without specification of the underlying defect or hazard, the classification defaults to Moderate severity for a voluntary Class II medical device recall.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of 72 kits of the DeRoyal EYE PACK medical device (Reference 89-8756.03) on November 3, 2022. The FDA classified this as a Class II recall.
The recalled product is identified by Lot 57344921 (expiration date November 1, 2026). This lot was distributed to customers across 23 U.S. states, including Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.
The public notice does not specify the reason for this recall. Healthcare facilities and consumers with the affected lot should contact DeRoyal Industries Inc or monitor FDA communications for further details and any necessary actions.
The recalled product
- Product
- DeRoyal EYE PACK, REF 89-8756.03
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Eye Care Device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: Lot 57344921 exp 11/1/2026
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03